Gemore Technology Co, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190988 | GIM-STIM OTC TENS/EMS System | August 16, 2019 |
| K150681 | GEMORE OTC TENS | May 12, 2015 |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | December 21, 2012 |
| K122948 | GEM-STIM COMBO STIMULATOR | December 21, 2012 |
| K120569 | GEMORE TENS SYSTEM | July 20, 2012 |
| K102933 | GEM-TONE BODY TRAINING SYSTEM | September 2, 2011 |
| K102926 | GEMORE MUSCLE CONDITIONER; | August 25, 2011 |
| K091833 | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. | October 16, 2009 |
| K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES | January 4, 2007 |
| K060222 | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP | April 28, 2006 |
| K042559 | GEM-TWIN TENS/ MODELS GM3XY/Z | November 17, 2004 |
| K032994 | GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) | December 16, 2003 |
| K032720 | GEM-STIM TENS, MODELS GM3XY AND GM3AXY | December 10, 2003 |
| K032719 | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) | December 10, 2003 |